Safety and Efficacy of Procalcitonin Guided Antibiotic Therapy in Adult Intensive Care Units (ICU's) (SAPS)
Recruitment status was Recruiting
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Purpose
This is a randomized controlled trial comparing standard-of-care therapy of infections in critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics consumption) and safety (mortality).
| Condition | Intervention |
|---|---|
|
Sepsis Severe Sepsis Septic Shock |
Other: procalcitonin-guidance |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Stop Antibiotics on Procalcitonin Guidance Study |
- Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy. [ Time Frame: Between day 1 and D28 ] [ Designated as safety issue: Yes ]
- Length of ICU stay [ Time Frame: Between D1 and D28 ] [ Designated as safety issue: Yes ]
- Acquisition costs of antibiotics [ Time Frame: Between D1-D28 ] [ Designated as safety issue: No ]Expressed in euro's
- Acquisition costs of procalcitonin [ Time Frame: Between D1-D28 ] [ Designated as safety issue: No ]Expressed in euro's
| Estimated Enrollment: | 2246 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| procalcitonin-guidance |
Other: procalcitonin-guidance
If procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued.
Other Name: PCT
|
|
standard-of-care
standard-of-care treatment of ICU infections based upon consensus guidelines and expert opinion
|
Other: procalcitonin-guidance
If procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued.
Other Name: PCT
|
Detailed Description:
Antibiotics are prescribed widely in intensive care units and are linked with high costs and the occurence of antimicrobial (multi)resistance. The optimal duration of antibiotic treatment is poorly known and often based on consensus guidelines.
SAPS is a multicenter, prospective, randomized, controlled open-label trial evaluating the equivalence/efficacy and safety of procalcitonin-guided treatment of infections in ICU patients versus a standard-of-care approach.
All patients that are admitted to the ICU and for whom systemic antibiotics are prescribed for presumed or proven bacterial infections are eligible for this trial. Patients will be randomized and stratified according to clinical diagnosis of severe sepsis and septic shock. Any patient over the age of 18, admitted to the ICU and receiving antibiotics for an assumed infection can be enrolled into this trial. Informed consent has to be obtained in writing from the patient of his/her relatives prior to inclusion. In the intervention group daily procalcitonin levels be performed and will generate a non-binding stopping advice when predefined stopping-rules have been reached. The ultimate decision to stop antibiotics will be at the discretion of the physician in both groups.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age over 18 years old
- receiving antibiotics for no more than 24 hours for an assumed or proven infection
- Informed consent
Exclusion Criteria:
- Failure to obtain written consent to participate
- Patients receiving prolonged antibiotic therapies (> 3 weeks, e.g. endocarditis, cerebral/hepatic abscess)
- Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasma gondii, Plasmodium spp.)
- Patients infected with Mycobacterium tuberculosis
- Patients entering the ICU for post-operative observation and/or on antibiotic prophylaxis with an estimated length of stay less then 24 hrs.
- Patients suffering from cystic fibrosis
- Severely immunocompromised patients such as patients with HIV and with a CD4 count of less than 200 cells/mm, neutropenic patients (<500 neutrophils per mL) or patients with solid organ transplantation
- Moribund patients
Contacts and Locations| Contact: Albertus Beishuizen, Dr. | 0031204443697 | beishuizen@vumc.nl |
| Contact: Evelien de Jong, MSc | 0031204443697 | ev.dejong@vumc.nl |
| Netherlands | |
| VU University medical center | Recruiting |
| Amsterdam, Netherlands, 1081 HV | |
| Contact: Evelien de Jong, MSc 0031204443824 ev.dejong@vumc.nl | |
| Principal Investigator: | Evelien de Jong, MSc | VU University medical center Amsterdam |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. A. Beishuizen, internist-intensivist, VU University Medical Center, Department of Intensive Care, Amsterdam |
| ClinicalTrials.gov Identifier: | NCT01139489 History of Changes |
| Other Study ID Numbers: | VU University medical center, NTR1861 |
| Study First Received: | March 8, 2010 |
| Last Updated: | June 7, 2010 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by VU University Medical Center:
|
Procalcitonin antibiotic therapy antibiotics |
sepsis infections biomarker |
Additional relevant MeSH terms:
|
Sepsis Toxemia Shock Shock, Septic Infection Systemic Inflammatory Response Syndrome |
Inflammation Pathologic Processes Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013